Gadolinium Based Contrast Agent Prompts Lawsuit

Scott Kappes

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A San Francisco couple has filed a lawsuit against Bayer and other drug manufacturers alleging that gadolinium based contrasted agents manufactured and distributed by the Defendants can cause patients to develop a severely painful and debilitating disease. William Paschal claims that he contracted Nephrogenic Systemic Fibrosis (NSF) from an intravenous injection of a gadolinium based contrast agent in January of 2008. Attorneys for the Paschals allege that the defendants failed to adequately test the compound on patients with kidney problems before introducing it to the market, placing millions of patients at risk.

NSF is characterized by discoloration, thickening, tightening and swelling of the skin after injections, according to the complaint. When NSF progresses it leads to painful inhibition of the ability to use the arms, legs, hands feet and other joints. When NSF progresses to the scarring of other body organs such as the lungs, heart, liver, it can lead to their inability to function properly and may lead to death.

Last year the FDA added its strongest, black box," warning to the label of gadolinium contrast agents to warn of an elevated risk of NSF associated with the imaging agents.

The plaintiffs' attorneys have charged the manufacturers with allegation that they failed to warn, design detect, and adequately test the compounds prior to their introduction to the U.S. market. They are also accused of negligence, concealment, and suppression of material facts.

No official response to the lawsuit has been issued by the defendants.